Engineering Site Lead

Posted Yesterday
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Hebron, KY, USA
In-Office
Senior level
Biotech • Consulting • Pharmaceutical • Manufacturing
The Role
Leads onsite engineering activities at an FDA-regulated manufacturing facility, coordinating CQV, automation, process, facilities, maintenance, quality, and operations teams. Drives project execution, schedules, technical issue resolution, equipment installation and startup, qualification, troubleshooting, upgrades, and continuous improvement. Ensures compliance with GMP, safety, quality, and site requirements while communicating priorities, risks, and project status to stakeholders.
Summary Generated by Built In

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, is a leading services provider delivering solutions to the Pharmaceutical, Biotechnology, Medical Device, Chemical, and Food industries across Engineering, Project Management, Validation, Compliance, Laboratory, and Computer Systems.

We are seeking a talented, dedicated professional committed to the highest ethical standards for the following direct-hire, permanent position:

Engineering Site Lead

We are seeking a hands-on Engineering Site Lead to provide onsite engineering leadership at an FDA-regulated manufacturing facility in Kentucky. This highly visible role will serve as the primary engineering point of contact, coordinating cross-functional teams and driving the successful execution of engineering, equipment, automation, and CQV activities.

Responsibilities
  • Lead and coordinate day-to-day onsite engineering activities

  • Serve as the primary engineering point of contact for site stakeholders

  • Coordinate cross-functional teams, including CQV, Automation, Process, Facilities, Maintenance, Quality, and Operations

  • Drive project and engineering execution, priorities, schedules, milestones, and deliverables

  • Proactively identify and resolve technical, schedule, and operational issues

  • Support commissioning, qualification, and validation (CQV) activities for manufacturing and laboratory equipment and systems

  • Support equipment installation, startup, upgrades, troubleshooting, and continuous improvement initiatives

  • Ensure engineering activities comply with GMP, safety, quality, and site requirements

  • Provide clear, timely communication on project status, risks, priorities, and issues to key stakeholders

Qualifications
  • 8+ years of engineering experience within pharmaceutical, biotechnology, medical device, or other FDA-regulated manufacturing environments

  • Demonstrated experience leading onsite engineering activities, projects, or cross-functional technical teams

  • Strong knowledge of GMP and CQV requirements

  • Hands-on experience with manufacturing and/or laboratory equipment and systems

  • Experience supporting equipment installation, startup, qualification, troubleshooting, or optimization

  • Familiarity with industrial automation and controls systems

  • Strong project execution, problem-solving, and organizational skills

  • Ability to independently manage priorities and drive issues through resolution

  • Excellent communication and stakeholder management skills

  • Ability to work onsite in Hebron, Kentucky (greater Cincinnati area)

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job—it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

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Skills Required

  • 8+ years of engineering experience within pharmaceutical, biotechnology, medical device, or other FDA-regulated manufacturing environments
  • Experience leading onsite engineering activities, projects, or cross-functional technical teams
  • Strong knowledge of GMP and CQV requirements
  • Hands-on experience with manufacturing and/or laboratory equipment and systems
  • Experience supporting equipment installation, startup, qualification, troubleshooting, or optimization
  • Familiarity with industrial automation and controls systems
  • Strong project execution, problem-solving, and organizational skills
  • Ability to independently manage priorities and drive issues through resolution
  • Excellent communication and stakeholder management skills
  • Ability to work onsite in Hebron, Kentucky
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The Company
154 Employees
Year Founded: 2019

What We Do

Pinnaql, Inc. is a professional services consulting firm providing quality, regulatory, and operational excellence solutions to biopharmaceutical, medical device, and CDMO companies worldwide. The company specializes in laboratory validation, engineering, and compliance, helping regulated life sciences organizations navigate manufacturing challenges, reduce execution risks, and accelerate the transition from lab innovation to commercial market readiness.

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